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Zohydro: Potent painkiller stirs debate over abuse vs. pain relief

Teresa Tanoos's picture
Powerful new painkiller creates controversy due to abuse potential.

When it comes to fighting heroin and the abuse of prescription medications, a potent new painkiller is stirring a debate that has one side fighting to protect the rights of chronic pain patients and the other side trying to fight the war on drugs.


At the center of the controversy is a new class of drugs that includes Zohydro, which was approved by the Food and Drug Administration late last year – against the recommendation by an internal advisory committee.

Since then, officials in many states have challenged the agency’s approval of the powerful new painkiller, including Vermont Gov. Peter Shumlin who just last week issued an emergency order that makes it more difficult for doctors to prescribe Zohydro.

Other state officials took similar actions because the drug can be highly addictive, not to mention crushed and snorted in a manner similar to heroin, making the war on drugs even harder.

This prompted Massachusetts Gov. Deval Patrick to ban Zohydro last week, which is the first time ever a drug has been banned in the state.

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Then, at the end of last year, there were the 28 attorneys general from states across America who banned together urging the FDA to revoke its approval of Zohydro or require that the drug’s maker reformulate the medication to make it less likely to be abused.

Nevertheless, San Diego-based Zogenix, the maker of Zohydro, insists the drug is no more potent than any other hydrocodone medication. The company also says that it is taking steps to ensure that both doctors and patients are educated about the drug’s risks.

And, just last Friday, the FDA and the Department of Health and Human Services (HHS) showed an impressive united front when HHS Secretary Kathleen Sebelius and FDA Commissioner Dr.Margaret Hamburg reaffirmed their support for Zohydro, calling for a balanced approach that not only helps prevent prescription drug abuse, but also preserves and protects the needs of patients suffering from severe chronic pain.

Zohydro belongs to a class of medicines called opiates or opioids, which includes other highly abused drugs like heroine, morphine and oxycodone.

Zohydro contains hydrocodone, as do other potent painkillers like Vicodin, which also contains acetaminophen, the active ingredient found in over-the-counter pain relievers like Tylenol.

1. Zogenix, News Release: FDA, HHS Reaffirm Support for Chronic Pain Patients Amid Zohydro ER Debate, April 4, 2014.
2. Food and Drug Administration, FDA Regulation of Controlled Substances: A Review of 2013, What to Expect in 2014, Douglas C. Throckmorton, MD, February 19, 2014.



I have been fighting rheumatoid arthritis for years. Nothing so far has worked. Need something to relieve this constant pain in my hands and feet.